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Brief Title: QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer
Official Title: QL1101A,a Biosimilar of Bevacizumab,in Combination With JS001,a Anti-pd-1 Antibody in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer: a Single-arm,Open-Label, Prospective, Single-center Study
Study ID: NCT04527068
Brief Summary: This is a single-arm,open-label, prospective, single-center Study of QL1101 and JS001 in patients with pMMR/MSS refractory metastatic colorectal cancer. QL1101 is a biosimilar of bevacizumab (Avastin) produced and provided by Qilu Pharmaceutical Co., Ltd., which has been marketed in China.It's a humanized monoclonal IgG1 antibody prepared by recombinant DNA technology. By binding to human vascular endothelial growth factor (VEGF), it inhibits the binding of VEGF to its receptor, blocks the signal transduction pathway of angiogenesis, and inhibits tumor cell growth. Be produced and provided by Shanghai Junshi Bioscience Co., Ltd. ,JS001(Tripleitriumab) is the first China-developed humanized monoclonal antibody against programmed death 1 (PD-1) approved for marketing in China. Antiangiogenic drugs combined with PD-1 monoclonal antibodies may reverse the insensitivity of pMMR/MSS refractory colorectal cancer to PD-1 inhibitors. The primary objective of this study is to investigate the safety and efficacy of the subjects who given the combination therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
the Second Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, Zhejiang, China
Name: Ying Yuan, M.D.
Affiliation: The Second Affiliated Hospital of Medical College of Zhejiang University
Role: PRINCIPAL_INVESTIGATOR